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EFFECT OF DASH DIET AND AEROBIC EXERCISES ON PREMENSTRUAL SYNDROME

Primary Purpose

Premenstrual Tension

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
dietary supplement ,electronic treadmill ,DASH diet.
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Premenstrual Tension

Eligibility Criteria

15 Years - 25 Years (Child, Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Fifty adolescent females were diagnosed with premenstrual syndrome.
  • Their age will be ranged from 15-to 25 years (3 years post-puberty).
  • Their body mass index (BMI) will range from 18-25.9 kg/m2.
  • All are of regular menstrual cycles.
  • All of them suffer from moderate and severe PMS.

Exclusion Criteria:

  • Any pathologic findings in the pelvic cavity as a polycystic ovarian syndrome, endometriosis, and pelvic inflammatory diseases.
  • Having irregular menstruation.
  • Any metabolic diseases.
  • Any history of gynecological intervention.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    medical treatment

    the same medication, in addition to DASH diet and aerobic exercise

    Arm Description

    Control group:Will be consisted of 25 females suffering from PMS will receive medical treatment in form of vit, B6, ca supplements and minerals (vitatron), once daily(1capsule), for 12 weeks.

    Study group: Will be consisted of 25 females suffering from PMS will Receive the same medication as in group (A) in addition to the DASH diet and aerobic exercise for 30 minutes,3 times/week,for 12 weeks.

    Outcomes

    Primary Outcome Measures

    Visual analogue scale (VAS)
    Visual analogue scale (VAS): Degrees of menstrual pain will be assessed using a VAS for all participants in both groups (A&B) before and after treatment, which is a method of representing .participants pain on a 10 cm linear scale. A score of zero mean "a very low degree of pain" and 10 mean "a very high degree of pain"
    Menstrual Distress Questionnaire (MDQ)
    Menstrual Distress Questionnaire (MDQ): The subjects decreased activity, lower back pain, tension or anxiety, breast tenderness, and headaches will assess for all participants in both group before and after treatment using Menstrual Distress Questionnaire (MDQ) .Each item will be score on a 5-point likert scale ,with 1 being "no pain at all" follow by "mild pain", "moderate pain", "slightly sever pain" ,and "extremely severe pain.

    Secondary Outcome Measures

    Full Information

    First Posted
    May 24, 2022
    Last Updated
    May 24, 2022
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05395169
    Brief Title
    EFFECT OF DASH DIET AND AEROBIC EXERCISES ON PREMENSTRUAL SYNDROME
    Official Title
    EFFECT OF DASH DIET AND AEROBIC EXERCISES ON PREMENSTRUAL SYNDROME
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 1, 2022 (Anticipated)
    Primary Completion Date
    September 1, 2022 (Anticipated)
    Study Completion Date
    October 1, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Hypothesis: There will be no effect of the DASH diet and aerobic exercise on premenstrual syndrome. Statement of the problem: Do the DASH diet and aerobic exercise have an effect on premenstrual syndrome?
    Detailed Description
    For some women, symptoms of PMS may be so severe that they miss work or school. Physical activity is a suitable method for the treatment of PMS and is the best method for all women to reduce pressure and balance the brain's chemical secretion. It seems that physical activity by increasing endorphins and reducing adrenal cortisol leads to the improvement of symptoms of PMS. DASH diet has been suggested to play an important role in the development, and treatment of some psychological disorders. For instance, it has been reported that a diet rich in fish, folate, and B-vitamins can alleviate the manifestations of depression. An established association was also shown between the dietary glycemic index (GI) and psychological diseases, depressive disorder, and mental functioning. Diets containing of "junk foods" (high energy and low nutritional) have been shown to increase the risk of mental illness, but a healthy diet is associated with less depressive symptoms and can improve mood .

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Premenstrual Tension

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    medical treatment
    Arm Type
    Experimental
    Arm Description
    Control group:Will be consisted of 25 females suffering from PMS will receive medical treatment in form of vit, B6, ca supplements and minerals (vitatron), once daily(1capsule), for 12 weeks.
    Arm Title
    the same medication, in addition to DASH diet and aerobic exercise
    Arm Type
    Experimental
    Arm Description
    Study group: Will be consisted of 25 females suffering from PMS will Receive the same medication as in group (A) in addition to the DASH diet and aerobic exercise for 30 minutes,3 times/week,for 12 weeks.
    Intervention Type
    Other
    Intervention Name(s)
    dietary supplement ,electronic treadmill ,DASH diet.
    Intervention Description
    Control group Will be receive medical treatment for 12 weeks. Study group Will be receive the same medication as in control group in addition to DASH diet and aerobic exercise for 12 weeks.
    Primary Outcome Measure Information:
    Title
    Visual analogue scale (VAS)
    Description
    Visual analogue scale (VAS): Degrees of menstrual pain will be assessed using a VAS for all participants in both groups (A&B) before and after treatment, which is a method of representing .participants pain on a 10 cm linear scale. A score of zero mean "a very low degree of pain" and 10 mean "a very high degree of pain"
    Time Frame
    assessment will be take 12 weeks
    Title
    Menstrual Distress Questionnaire (MDQ)
    Description
    Menstrual Distress Questionnaire (MDQ): The subjects decreased activity, lower back pain, tension or anxiety, breast tenderness, and headaches will assess for all participants in both group before and after treatment using Menstrual Distress Questionnaire (MDQ) .Each item will be score on a 5-point likert scale ,with 1 being "no pain at all" follow by "mild pain", "moderate pain", "slightly sever pain" ,and "extremely severe pain.
    Time Frame
    assessment will be take 12 weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    15 Years
    Maximum Age & Unit of Time
    25 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Fifty adolescent females were diagnosed with premenstrual syndrome. Their age will be ranged from 15-to 25 years (3 years post-puberty). Their body mass index (BMI) will range from 18-25.9 kg/m2. All are of regular menstrual cycles. All of them suffer from moderate and severe PMS. Exclusion Criteria: Any pathologic findings in the pelvic cavity as a polycystic ovarian syndrome, endometriosis, and pelvic inflammatory diseases. Having irregular menstruation. Any metabolic diseases. Any history of gynecological intervention.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Azaa Barmoud, professor
    Phone
    01008410312
    Email
    drazzakassab@yahoo.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

    Learn more about this trial

    EFFECT OF DASH DIET AND AEROBIC EXERCISES ON PREMENSTRUAL SYNDROME

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